FDA-Device2022-08-10Class II
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Medtronic Inc
Hazard
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Sold states
US Nationwide distribution.
Affected count
84 units
Manufactured in
710 Medtronic Pkwy Mailstop Ls245, N/A, Minneapolis, MN, United States
Products
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2022Don't want to check this manually?
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